ERC-RMB Represents State of the Art in Absorbable Magnesium Alloys at ASTM-FDA Workshop

Achievement date: 
2013
Outcome/accomplishment: 

Researchers from the NSF-funded Engineering Research Center (ERC) for Revolutionizing Metallic Biomaterials (RMB), headquartered at North Carolina Agricultural and Technical State University, presented the  state of the art in absorbable magnesium alloys at a November 2012 Workshop on Absorbable Medical Devices: Lessons Learned from Correlations of Bench Testing and Clinical Performance . The event, which was cosponsored by the American Society for Testing and Materials (ASTM) and the Food and Drug Administration (FDA), was unique in bringing researchers working in both polymers and metals together to share their experiences and challenges.

Impact/benefits: 

Some 150 expert academic and industrial researchers, clinicians, and regulators actively engaged in absorbable materials R&D around the globe participated in the workshop, which was held at FDA’s White Oak, MD, campus. The ERC-RMB presentations contributed to a pool of information that allowed participants to draw meaningful comparisons between the challenges faced by the erodible metals and the absorbable polymers communities, and how they are being addressed. In addition, ERC-RMB participants had the opportunity to build and strengthen relationships with important industrial colleagues, ASTM, FDA, and the International Standards Organization (ISO).

Explanation/Background: 

The use of absorbable materials in medical devices offers great promise. However, the material must be able to withstand intense demands. Laboratory testing to predict clinical performance of fully absorbable medical devices is not yet defined. This workshop discussed the use of absorbable materials (including synthetic polymers as well as erodible metals) in medical devices across a broad range of circumstances with the aim of defining successful and unsuccessful methods to predict clinical performance. ERC-RMB presentations included:

Dr. Frank Witte, Associate Professor of Experimental Orthopedics at the Hannover Medical School and Global Coordinator for ERC-RMB, represented the collective views of the absorbable metals community in a presentation titled “Current Opinion of the Science Community on Guidelines and Testing of Biodegradable Metals.” Suggestions for standard materials screening tests, device performance tests, and reference standard alloys were discussed.

Dr. Yeoheung Yun,  Associate Professor of Bioengineering at North Carolina A&T state University and leader for the ERC-RMB’s studies towards standardization of corrosion characterization studies gave a presentation  titled: “Testing Corrosion for Biodegradable Mg alloys: Science, Current Methods, and Limitation”. In his talk, Dr. Yun discussed the challenges faced in testing materials absorption, particularly in correlating laboratory test results with clinical performance. 

Dr. Lisa Ferrara, Owner and President of Orthogenetic Testing Technologies and Chair of the ERC-RMB Industrial Advisory Board, discussed “Mechanical Evaluation of Biodegradable Magnesium and Magnesium Alloys: Identifying the Necessary Testing, Challenges, and Pitfalls for Biomaterial Characterization”. Dr. Ferrara shared her experience in testing biomaterials testing with the group, emphasizing the potential pitfalls resulting from poor study design and the need for a team approach to avoid these problems.